HPV-related Oropharyngeal and Uncommon Cancers Screening (HOUSTON)

• ClinicalTrials.gov Identifier: NCT02897427
• Recruitment Status: Recruiting
• First Posted: September 13, 2016
• Last Update Posted: December 20, 2018
• Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): M.D. Anderson Cancer Center

Study Description

Brief Summary:

This trial studies the screening of human papillomavirus (HPV)-related oropharyngeal and uncommon cancers. Learning the relationship between HPV and cancer risk in men who test positive for HPV antibodies may help doctors to develop early methods of screening for certain types of cancer, and screening for HPV may help doctors to learn which patients may be at a higher risk for developing certain types of cancer.

Condition or disease	Intervention/treatment
Health Status Unknown	Other: Biomarker Analysis; Procedure: Biospecimen Collection; Procedure: Ultrasonography

Detailed Description:

PRIMARY OBJECTIVES:

I. To estimate the cumulative 5-year incidence rate of HPV-related malignancies, oropharyngeal, anal, and penile cancer, in men aged 50-64 who test serologically positive for antibodies to HPV 16 E antigens.

SECONDARY OBJECTIVES:

I. To evaluate the association of persistent oral HPV deoxyribonucleic acid (DNA) and subsequent diagnosis of oropharyngeal cancer.

II. To estimate the prevalence of serological antibodies to HPV E antigens in men aged 50-64.

III. To investigate behavioral risk factors for HPV-related malignancies in men.

IV. To compare the incidence rates of HPV-related malignancies, oropharyngeal, anal, and penile cancer, between the matched HPV serologically positive and negative men.

EXPLORATORY OBJECTIVES:

I. To evaluate the performance of serological testing of HPV, when used for screening men for HPV-related malignancies.

II. To evaluate the feasibility and performance of narrow band imaging to diagnose oropharyngeal cancer.

III. To evaluate the feasibility and performance of transcervical ultrasonography of the neck lymph nodes and oropharynx for early diagnosis of oropharyngeal cancer.

IV. To evaluate the performance of anoscopy and HPV/cytology testing of anal swab (anal Papanicolaou [Pap]) to diagnose anal cancer.

V. To determine the feasibility of nucleic acid-based techniques (circulating HPV16 DNA [cvDNA] in serum as well as oral HPV16 DNA and integrated HPV16 DNA in oral rinse and swabs) to refine high-risk group selection for screening and to facilitate oropharyngeal localization of cancers and pre-cancers within a group undergoing screening.

VI. To evaluate T cell response to E2, E6, and E7 antigens as a diagnostic biomarker for HPV-related cancer.

VII. To evaluate the association between oral HPV16 infection and the oral microbiota as well as factors that modify any such association.

OUTLINE:

STAGE I: Participants undergo collection of blood and oral gargle samples.

STAGE II: Participants complete a head and neck exam by using brushing of the oropharyngeal mucosa, a thorough oropharyngeal exam including narrow band imaging, undergo collection of oral gargle sample, transcervical ultrasonography of the neck lymph nodes and oropharynx, anoscopy, and complete Papanicolaou/HPV testing. Participants undergo repeat oropharyngeal screening, oral HPV DNA test, oral HPV integration testing, and ultrasound once every 6 months for 5 years. Participants also undergo collection of blood.

Study Design

• Study Type: Observational
• Estimated Enrollment: 5000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: HPV-Related Oropharyngeal and Uncommon Cancers Screening Trial of meN (HOUSTON Study)
• Actual Study Start Date: March 28, 2017
• Estimated Primary Completion Date: March 28, 2027
• Estimated Study Completion Date: March 28, 2027

Groups and Cohorts

Group/Cohort

Intervention/treatment

Screening (specimen collection, HPV testing); STAGE I: Participants undergo collection of blood and oral gargle samples. STAGE II: Participants complete a head and neck exam by using brushing of the oropharyngeal mucosa, a thorough oropharyngeal exam including narrow band imaging, undergo collection of oral gargle sample, transcervical ultrasonography of the neck lymph nodes and oropharynx, anoscopy, and complete Papanicolaou/HPV testing. Participants undergo repeat oropharyngeal screening, oral HPV DNA test, oral HPV integration testing, and ultrasound once every 6 months for 5 years. Participants also undergo collection of blood.

Other: Biomarker Analysis; Complete HPV testing; Procedure: Biospecimen Collection; Undergo collection of blood and oral gargle samples; Procedure: Ultrasonography; Undergo transcervical ultrasonography; Other Names: 2-Dimensional Grayscale Ultrasound Imaging; 2-Dimensional Ultrasound Imaging; 2D-US; ULTRASOUND; Ultrasound Imaging; Ultrasound Test; Ultrasound, Medical; US

Outcome Measures

Primary Outcome Measures :

1. Cancer detection rate of the seropositive group [ Time Frame: Up to 5 years ]
   Will use the proportion equality test to compare the cancer detection rate of the seropositive group using the screening strategy with the historical rate of 0.08 (4/50). To evaluate the performance of the new techniques for early detection, will test whether the proportion of patients diagnosed at stage I, II, or III from the screening strategy is larger than the historical rate of 17.7% using the proportion equality test. Will further compute and compare the pre-cancer detection rates with the historical information.
2. Prevalence of serum antibodies to human papillomavirus (HPV)16 E antigens [ Time Frame: Up to 5 years ]
   Will calculate the prevalence of serum antibodies to HPV16 E antigens along with 95% confidence intervals. Will use descriptive statistics to summarize the demographic and sexual behavior characteristics of study participants overall and by HPV16 E antibody status (positive, negative). Logistic regression models will be used to determine the association between serostatus or oral HPV infection status and demographic, socioeconomic, and behavioral factors.

Biospecimen Retention:   Samples With DNA

blood sample for serologic testing and oral gargle sample for oral HPV testing

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 64 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

MDACC Clinics

Criteria

Inclusion Criteria:

• Stage 1 Inclusion Criteria: United States (US) resident
• Stage 1 Inclusion Criteria: Fluent in English
• Stage 1 Inclusion Criteria: Sign an approved informed consent document

• Stage 2 (longitudinal study) Inclusion Criteria:

  • Eligible for and enrolled in Stage 1
  • Test positive to HPV16 E antibodies; be identified as a negative control; test positive for oral HPV16 infection by oral rinse; or test positive for cvDNA
  • Sign an approved informed consent document

Exclusion Criteria:

• Stage 1 Exclusion Criteria: Patients with previously documented squamous cell carcinoma of the oropharynx, anus, or penis
• Stage 1 Exclusion Criteria: Received radiation cancer therapy to the head and neck in the past
• Stage 1 Exclusion Criteria: On active cancer therapy now or in the past 6 months
• Stage 1 Exclusion Criteria: Ever had a transplant (stem cell, bone marrow, or solid organ)
• Stage 1 Exclusion Criteria: Patients who received blood transfusions in the last 6 months
• Stage 1 Exclusion Criteria: Other medical or psychiatric illness or social situation that would limit study compliance
• Stage 2 (longitudinal study) Exclusion Criteria: Any seronegative and cvDNA-negative man who tests negative for oral HPV16 DNA by swab at two consecutive follow-up visits will be excluded from further follow-up. Any man who is seropositive, cvDNA-positive, or has evidence of integration at any time will continue to be followed regardless of oral HPV16 status

Contacts and Locations

Contacts

Contact: Erich M. Sturgis; 713-792-6920; esturgis@mdanderson.org

Locations

United States, Texas

M D Anderson Cancer Center; Recruiting

Houston, Texas, United States, 77030

Contact: Erich M. Sturgis 713-792-6920

Principal Investigator: Erich M. Sturgis

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Erich Sturgis; M.D. Anderson Cancer Center

More Information

Additional Information:

MD Anderson Cancer Center Website 

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT02897427
• Other Study ID Numbers: 2016-0109; NCI-2018-02604 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); 2016-0109 ( Other Identifier: M D Anderson Cancer Center ); P30CA016672 ( U.S. NIH Grant/Contract )
• First Posted: September 13, 2016
• Last Update Posted: December 20, 2018
• Last Verified: December 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No